NCT05810753

Brief Summary

The goal of this study is to assess the feasibility and acceptability to community-dwelling older adults of implementing a precise prescription of oral nutritional supplementation (the SPOONful intervention).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 20, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

March 30, 2023

Last Update Submit

March 13, 2024

Conditions

MalnutritionHealthy Aging

Keywords

Oral nutritional supplementationOlder adultsPrescription

Outcome Measures

Primary Outcomes (3)

  • Attrition rate

    The primary outcome is the feasibility and acceptability of the SPOONful intervention which includes an assessment of attrition rate which will be derived by dividing the number of withdrawn participants (calculated as the number of people retained to the end of the intervention/control period subtracted from the total number randomised) by the number originally randomised.

    From randomisation (post-familiarisation) to end of intervention week 3.

  • Completion of self-report data-collection booklet denoting ONS consumption

    The primary outcome is the feasibility and acceptability of the SPOONful intervention which includes an assessment of participants' ability to complete the self-report data-collection booklet denoting their ONS consumption. Completion of data-collection booklet with times of ONS intake will be calculated as the percentage of blank/incomplete data cells.

    From start of week 1 to end of week 3

  • Daily consumption of Oral Nutritional Supplementation as per prescription.

    The primary outcome is the feasibility and acceptability of the SPOONful intervention which includes an assessment of daily consumption of ONS as prescribed will be measured as the percentage of instances where participants did not adhere to the prescription.

    From start of week 1 to end of week 3

Study Arms (2)

SPOONful

EXPERIMENTAL

Participants will be asked to consume one ONS with their breakfast, and one with their lunch, daily for three weeks.

Behavioral: SPOONful

Control

NO INTERVENTION

Participants will be asked to consume two ONS daily, in addition to their regular diet, for three weeks without any precise instruction regarding when to consume the ONS during the day (standard care).

Interventions

SPOONfulBEHAVIORAL

Participants will be asked to consume two ONS daily, in addition to their regular diet, for three weeks. Participants will be asked to consume one ONS with their breakfast, and one with lunch.

SPOONful

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Be aged ≥70 years.
  • Be living independently in the community.
  • Be able to self-feed.
  • Score \>12 on The Montreal Cognitive Assessment (5-minute telephone version).
  • Not be classified as High Risk of Malnutrition as assessed by the Malnutrition Universal Screening Tool
  • Not have a BMI ≥40.
  • Not have diabetes, a diagnosed eating disorder, a history of gastric/digestive/metabolic/cardiovascular/anosmia/renal disease, galactosaemia or another issue negatively impacting eating.
  • Not have an allergy/intolerance/dislike or previous experience of regularly taking ONS.
  • Regularly eat breakfast and lunch (≥5 times per week).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 12, 2023

Study Start

May 20, 2023

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Available upon request once the study findings have been published.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Intention to publish date 1/12/2024
Access Criteria
Anonymous data will be shared with all who request access via email for novel analyses or re-analysis of the study outcomes. This will be administered by Dr Chris McLeod.

Locations

GB(1)